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510(k) Data Aggregation
K Number
K083272Device Name
SKINCLEAR Q-SWITCHED ND:YAG LASER
Manufacturer
GLOBAL USA DISTRIBUTION, LLC.
Date Cleared
2008-12-16
(40 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL USA DISTRIBUTION, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SkinClear Q-Switched Nd: YAG Laser is indicated at the 1064 nm wavelength for dark ink tattoo removal, the removal of pigmented lesions. and the removal or lightening of hair. Indicated for use on all skin types (Fitzpatrick I-IV)
The SkinClear Q-Switched Nd: YAG Laser is indicated at the 532 nm wavelength for red ink tattoo removal, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, ephildes). Indicated for use on all skin types (Fitzpatrick I-IV)
Device Description
The SkinClear Q-Switched Nd: YAG Laser is composed of a console which houses a power supply, electronic circuit board, cooling system, a liquid crystal display screen (LCD), a handpiece which contains the light source which is connected to the console by a power cord, and an on/off footswitch.
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K Number
K082028Device Name
LASERPEEL SOFT-MET MODIFIED ERBIUM LASER
Manufacturer
GLOBAL USA DISTRIBUTION, LLC.
Date Cleared
2008-08-08
(22 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL USA DISTRIBUTION, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated at 2940 nm for Fitzpatrick skin types I-V for coagulation, vaporization, ablation or cutting of soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology. Specifically indicated for skin resurfacing, treatment of wrinkles, and superficial skin lesions.
Device Description
The LaserPeel Soft-MET Modified Erbium Laser is a compact self-contained device that delivers a beam of laser energy at an infrared wavelength of 2940 nm to the treatment site. The LaserPeel Soft-MET Modified Erbium Laser consists of four primary components:
1. A console which houses the power supply, electronics, cooling system, and liquid crystal display screen (LCD);
2. A handpiece which contains the laser cavity and optical delivery system and is connected to the console by an umbilical cord:
3. An on/off footswitch; and
4. An integrated trolley/cart.
The LaserPeel Soft-MET Modified Erbium Laser is not battery operated, but is controlled and operated with the aid of computer software.
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K Number
K082033Device Name
NANNOLIGHT INTENSE PULSED LIGHT SYSTEM
Manufacturer
GLOBAL USA DISTRIBUTION, LLC.
Date Cleared
2008-07-31
(14 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL USA DISTRIBUTION, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
530 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign pigmented lesions including dyschromia, hyperpigmentation, melasma, and epheleides (freckles) * Benign cutaneous lesions including warts, scars, and striae
560 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. * Benign cutaneous lesions including warts, scars, and striae
585 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-V for the treatment of: * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. * Benign cutaneous lesions including warts, scars, and striae
640 - 1400 nm wavelength is indicated for Fitzpatrick skin types I-IV for the treatment of: * The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction
690 - 1400 nm wavelength is indicated for Fitzpatrick skin types IV and V for the treatment of: * The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction
Device Description
The NannoLight Intense Pulsed Light System is composed of a console which houses a power supply, electronic circuit board, cooling system, a liquid crystal display screen (LCD) which displays the settings of power, pulse width, and pulse count which are manually adjusted by a touch screen display panel, a handpiece which contains the light source connected to the console by a power cord, and an on/off footswitch. The NannoLight Intense Pulsed Light System is not battery operated, but is controlled and operated with the aid of computer software.
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K Number
K080697Device Name
SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER
Manufacturer
GLOBAL USA DISTRIBUTION, LLC.
Date Cleared
2008-04-07
(26 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL USA DISTRIBUTION, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1064 nm: Intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and the treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos, solar lentigos, Café au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae. Indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin.
1320 nm: For use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue. For use in the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.
Device Description
The SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser is a compact self-contained device that delivers a beam of laser energy at infrared wavelengths of 1064 nm and 1320 nm to the treatment site. The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser consists of six (6) primary components:
1. Laser console;
2. Internal computer;
3. Control panel and display;
4. Optical delivery system;
5. Hand set with integrated cooling (chilled sapphire optical window);
6. Foot switch
The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser is not battery operated, but is controlled and operated with the aid of computer software.
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